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  • A milestone drawn on a chalk board Addressing Cybersecurity’s ‘First Mile Problem’
    Gabrielle Hirneise
    Aug 25, 2021
    MedCrypt cybersecurity experts Axel Wirth and Vidya Murthy explain how healthcare systems and medical device companies alike can account for known cybersecurity vulnerabilities, as shared by manufacturers, to minimize the risk of a cyber attack.
  • Cybersecurity Roundtable What’s Next for Health Technology Cybersecurity? Leading Experts Weigh In
    Brian Stallard
    Aug 25, 2021
    Ask anyone in healthcare technology management (HTM) what worries them most about the future of medical devices and they’ll likely say the same thing: cybersecurity.
  • Man in business suit point to a figure ascending stairs. New HTM Guidance Covers Compliance and Recognition “From the Basement to the Board Room”
    Brian Stallard
    Aug 23, 2021
    Thought leaders and subject-matter experts from AAMI and its robust HTM community have crafted two valuable resources that can be immediately put to use by ambitious and professional HTM departments looking to increase their compliance and recognition.
  • BMET Apprentice Caleb Barber repairs a medical device ReNew Biomedical Mints First CABT-Certified Apprentices
    Chris Hayhurst
    Aug 23, 2021
    Two trainees at ReNew Biomedical Services have become the first participants in AAMI’s BMET Apprenticeship Program to earn their CABT certifications, showcasing the effectiveness of this new pipeline for BMET training.
  • FDA_logo_high_quality_sq_200-1 FDA Issues Cyber Vulnerability Alert for Medical Devices Using BlackBerry RTOS
    Randolph Fillmore
    Aug 18, 2021
    FDA has notified patients, healthcare providers, and manufacturers of cybersecurity vulnerabilities that could affect certain medical devices.
  • Medical devices in a hospital room Mayo Clinic Details Best Practices in the ‘Healthcare Internet of Things’
    Jennifer Peters
    Aug 18, 2021
    Mayo Clinic HTM head Keith Whitby describes how to better manage the unique corner of the healthcare Internet of Things that is medical devices through processes such as micro-segmentation.
  • A doctor in face mask and gloves interacts with a tablet. HIMSS21: Is a ‘Hybrid Healthcare’ System on the Horizon?
    Gabrielle Hirneise
    Aug 18, 2021
    In light of developments spurred by the COVID-19 pandemic, cybersecurity and HTM experts shared their future plans for implementing partially-remote healthcare systems during a HIMSS21 panel.
  • Screenshot of the message victims of the WannaCry ransomware attack received. Cyberthreats Inspire a New Course for HTM Professionals
    Brian Stallard
    Aug 17, 2021
    AAMI will be offering a new training course: “Medical Cybersecurity 101 for HTM Professionals.” The Sep 21-23 course will provide the knowledge and skills to effectively plan for, implement, and manage a medical device security program.
  • FDA_logo_high_quality_sq_200-1 FDA Expands Its Portfolio of Regulatory Science Tools to Accelerate Innovation
    Martha Vockley
    Aug 17, 2021
    The FDA is making more regulatory science tools publicly available to help early-stage innovators demonstrate the safety and effectiveness of their healthcare technology.
  • FDA_logo_high_quality_sq_200-1 FDA Announces Device User Fees for 2022
    Gavin Stern
    Aug 11, 2021
    The Food and Drug Administration (FDA) has announced increases for its medical device user fees for fiscal year 2022, which go into effect on October 1. The average increase in fees is 2.5%, which is lower than than increases in recent years of 7% (2021) and 6% (2020).
  • A senior woman video calls with her doctor using a tablet. Healthcare Organizations Warn of ‘Telehealth Cliff’
    Fran Kritz
    Aug 11, 2021
    More than 400 healthcare organizations have sent a letter to the U.S. Congress warning of a “telehealth cliff” once the COVID-19 public health emergency—and temporary regulatory changes—eventually end.
  • A key made up of 1s and 0s Study: Many Health Apps Pose Data Privacy Risks
    Fran Kritz
    Aug 11, 2021
    A recent study published in the British Medical Journal (BMJ) found that many mobile health apps (mHealth apps) include code that could potentially collect user data. For the study, researchers from Macquarie University in Sydney looked at close to 16,000 free mHealth apps and compared to close to 9,000 non-health apps.
  • GenericCybersecurity_310133756 Threat Modeling and Penetration Testing for Cybersecurity
    Martha Vockley
    Aug 10, 2021
    With cybersecurity threats on the rise in healthcare, it’s vital for product developers to identify risks and mitigate any vulnerabilities to healthcare technology. But what’s the best way to go about this?
  • FDA_logo_high_quality_sq_200-1 Tips, Best Practices, and Updates on FDA 510(k) Program
    Martha Vockley
    Aug 10, 2021

    Have you ever felt like your 510(k) submission for premarket approval of a medical device enters a black box when you hand it over to the Food and Drug Administration (FDA)?

  • Keys to Succession Planning in HTM
    Martha Vockley
    Aug 4, 2021
    Are there opportunities you’re missing because you have neither the time nor the available talent to pursue them? Are you confident you can consistently recruit new talent and retain the talent you have? How prepared are you if someone were to leave your organization?
  • SonarMed in use Pediatric Airway Monitoring System Launched by Medtronic
    Fran Kritz
    Aug 4, 2021
    A device designed specifically for neonates and infants, Medtronic’s SonarMed airway monitoring system, recently launched in the United States and checks for unplanned extubations, which can result in insufficient oxygen to the brain within just a few seconds.
  • janet_woodcock_900x900_2 FDA Commissioner Seeks Resources to Address Medical Device Shortages
    Fran Kritz
    Aug 4, 2021
    Janet Woodcock, MD, acting commissioner of the FDA, recently asked Congress for additional powers and funding to help prevent medical device shortages. In a blog post, Woodcock said that the COVID-19 pandemic had “exposed great weaknesses in the medical device supply chain" that the U.S. needs to resolve to ensure it is better prepared for future crises.
  • A technician with a clipboard inspects a medical device next to a hospital patient Just Say ‘No!’ to Insecure Medical Equipment
    Steven D. Baker
    Aug 3, 2021
    Until healthcare delivery organizations begin standing their ground and demanding that medical device manufacturers address vulnerabilities before purchasing equipment, security shortcomings will continue to proliferate, warns CYBER INSIGHTS guest author Steven D. Baker, PhD, AAMIF.
  • Child patient and her mother smile at one another in a pediatric hospital. Health Equity: The Common Denominator in FDA Initiatives for Pediatric Device Innovation
    Martha Vockley
    Jul 28, 2021
    The U.S. FDA is contributing to a new public-private initiative to create a strategic framework aimed at transforming the pediatric medical device ecosystem. The agency is also expanding efforts to collect crucial, real-world data.
  • FDA_logo_high_quality_sq_200-1 FDA Revokes Respirator, Decontamination Equipment Emergency Use Authorizations
    Fran Kritz
    Jul 28, 2021
    Citing sufficient U.S. supply, the FDA recently revoked emergency use authorizations (EUAs) for disposable respirators not approved by National Institute of Occupational Safety and Health (NIOSH), as well as some decontamination equipment.